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Qiming Wang



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    MA03 - Clinomics and Genomics (ID 119)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA03.02 - Genetic Variants in ERAP1 and NCF2 in the MHC Class I Related Genes Are Associated with Non-Small Cell Lung Cancer Survival (Now Available) (ID 1491)

      10:30 - 12:00  |  Author(s): Qiming Wang

      • Abstract
      • Presentation
      • Slides

      Background

      Adaptive immunity, particularly the presence of tumor-infiltrating CD8+ T cells, is crucial in the control of tumor cells and preventing overall cancer progression. However, the process of CD8+ T cells recognizing and killing tumor cells depends on the expression of MHC class I (MHCI) complex presented on tumor cell surface.

      Method

      In the present study, we performed a two-phase analysis of two independently published genome-wide association studies (GWASs) to evaluate associations between genetic variants in the MHCI-related gene-set and overall survival (OS) of patients with non-small cell lung cancer (NSCLC). In the discovery GWAS dataset, we performed multivariate Cox proportional hazards regression with Bayesian false-discovery probability for multiple test corrections and evaluated associations between 9,718 single-nucleotide polymorphisms (SNPs) in 102 genes and survival of 1,185 NSCLC patients. After validation in another GWAS dataset, we performed linkage disequilibrium, function prediction and a multivariate stepwise Cox proportional hazards regression analysis.

      Result

      We found that two independent, potentially functional SNPs in two genes (ERAP1 rs469783 T>C and NCF2 rs10911362 C>T) were significantly associated with NSCLC survival, and their meta‐analysis showed an adjusted hazards ratio (HR) of 0.83 [95% confidence interval (CI) =0.77–0.89] and P meta =  8.2×10-7; 1.31 (1.06-1.73) and P meta = 0.0009; respectively. A genetic score of unfavorable genotypes of these two SNPs revealed a decreased OS in a dose–response manner (P trend < 0.0001). Further expression quantitative trait loci (eQTL) analysis showed significant associations between the genotypes and mRNA expression levels. Furthermore, the expression levels of these genes in tumor and normal tissues were different and had an effect on patient survival as well.pdf转图片- 老版.jpgpdf转图片- 老版11.jpg

      Conclusion

      Taken together, the genetic variant of the ERAP1 rs469783 and NCF2 rs10911362 from the MHCI pathway genes may be a promising predictor of survival in NSCLC patients via ERAP1 and NCF2 expression alteration.

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    MA25 - Precision Medicine in Advanced NSCLC (ID 352)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA25.09 - Navigating Anlotinib Precision Therapy Through the Genetic Profiling of Circulating DNA in Non-Small Cell Lung Cancer Patients (Now Available) (ID 1055)

      14:30 - 16:00  |  Author(s): Qiming Wang

      • Abstract
      • Presentation
      • Slides

      Background

      Anlotinib is an oral multi-targeted anti-angiogenic drug, and its clinical predictor for non-small cell lung cancer (NSCLC) patients is still elusive. The aim of this study is to screen predictor for anlotinib via non-invasive genetic profiling of plasma cell free DNA and circulating tumor DNA (cfDNA & ctDNA).

      Method

      Tumor-specific target capture to profile the circulating DNA of ALTER0303 (Evaluating NSCLC clinical anti-tumor efficacy through anlotinib therapy) study participants. Acquired mutations were screened out via comparing genetic profiling between baseline (BL) and progression disease (PD), and were used for anlotinib stratification. Based on the sequencing data at BL, tumor mutation index (TMI) was established from three independent predictors germline and somatic mutation burden (G+S MB), nonsynonymous and synonymous mutation burden (N+S MB) and unfavorable mutation score (UMS), and was used for predicting anlotinib responders. In addition, TMI combined with IDH1Exon4 mutation status also be examined for serving as predictor for anlotinib stratification.

      Result

      Our data firstly indicated no benefit (NB, PFS ≤ 45 days) patients can be mainly excluded via analysis of ARID1A and BRCA2 genetic profiling. Secondly, for the no durable benefit (NDB, 45 days < PFS ≤ 130 days) and durable clinical benefit (DCB, PFS > 130 days) patients, harboring lower mutation burden (G+S MB, N+S MB, and UMS) received more benefit from anlotinib therapy. Subsequently, we found the predictor-TMI can predict anlotinib responders upon discovery cohort (Median PFS: 210 days vs 126 days; p = 0.0238; AUC = 0.77), and validation cohort (Median PFS: 210 days vs 127 days; p = 0.0352) and all patients (Median PFS: 210 days vs 127 days; p = 0.0044) more effectively. Furthermore, the IDH1Exon4 mutation was identified as an unfavorable factor to anlotinib therapy under TMI-based stratification. Lastly, the TMI plus IDH1Exon4 mutation status predict response to anlotinib significantly (Median PFS: 210 days vs 127 days, p < 0.0001, AUC = 0.90; Median OS: 423 days vs 162 days, p < 0.0001, AUC = 0.80).

      Conclusion

      This study provides circulating DNA sequencing-based stratification for underlying anlotinib responders via non-invasive approach, and thus potentially improve clinical outcome for NSCLC patients at 3rd line.

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    OA02 - A New Vision of Targets and Strategies (ID 120)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
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      OA02.03 - The Third Generation EGFR Inhibitor (EGFR-TKI) HS-10296 in Advanced NSCLC Patients with Resistance to First Generation EGFR-TKI (Now Available) (ID 766)

      10:30 - 12:00  |  Author(s): Qiming Wang

      • Abstract
      • Presentation
      • Slides

      Background

      HS-10296 is an oral, potent, high selective third generation EGFR tyrosine-kinase inhibitor (EGFR-TKI) for sensitizing mutations, and the EGFR Thr790Met (T790M) resistance mutation which has been demonstrated by phase I study. This phase II, open-label, multicenter single-arm study was designed to confirm the efficacy and safety of HS-10296 in a large population of non-small-cell lung cancer (NSCLC) patients with EGFR T790M mutation, who had progressed after first generation EGFR-TKI treatment.

      Method

      Patients aged at least 18 years with centrally confirmed EGFR T790M-positive mutations, locally advanced or metastatic (stage IIIB/IV) NSCLC after first generation EGFR-TKI treatment received HS-10296 110 mg orally once daily until disease progression, or intolerable toxicity, or patient withdrawal. Patients with asymptomatic, stable brain metastases not requiring steroids were allowed to enroll. The primary endpoint was the objective response rate (ORR) by independent central review using Response Evaluation Criteria in Solid Tumors, version 1.1 every 6 weeks. Response endpoints (ORR and disease control rate [DCR]) were assessed in response analysis set. Secondary end points including progression-free survival (PFS), duration of response (DoR), depth of response (DepOR), overall survival (OS) and safety were evaluated in full analysis set. The final data cutoff was on Jan 5, 2019. The study is still ongoing.

      Result

      Totally, 244 patients (median age 60.8) entered study in 36 sites in mainland China (189 patients) and Taiwan (55 patients) between May 16, 2018 to Oct 23, 2018. 2 patients were excluded from the evaluable for response analysis set (n=242) due to absence of measurable disease at baseline by independent central review. At data cutoff, 182 (74.6%) patients remained on treatment. The median duration of follow-up was 4.7 months. 160 of 242 patients achieved confirmed partial responses by independent central review. The ORR was 66.1% (95% CI: 59.8-72.1). The DCR was 93.4% (95% CI: 89.5-96.2). The most common adverse reactions (≥ 10%) were blood creatine phosphokinase increased (43 [17.6%]), aspartate aminotransferase increased (29 [11.9%]), pruritus (28 [11.5%]), rash (28 [11.5%]) and alanine aminotransferase increased (26 [10.7%]). The most common all-causality grade 3 and 4 adverse events were blood creatine phosphokinase increased (14 [5.7%]) and hyponatraemia (4 [1.6%]). Serious adverse events were reported in 30 (12.3%) patients, of which 19 (7.8%) were investigator assessed as possibly treatment-related to HS-10296. Three deaths were due to adverse events; one was related to cardiopulmonary failure, other two events occurred after disease progression. There was no interstitial lung disease during study treatment.

      Conclusion

      HS-10296 has demonstrated good clinical benefit with minimal toxicity in patients with EGFR T790M-positive NSCLC patients who have progressed after first generation EGFR-TKI treatment. The Phase III study has already launched comparing HS-10296 with gefinitib in advanced NSCLC patients with EGFR sensitizing mutations. (The study was sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.; ClinicalTrials.gov number, NCT02981108)

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    OA03 - Systemic Therapies for SCLC: Novel Targets and Patients' Selection (ID 121)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Now Available
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      OA03.02 - Effect of Anlotinib in Advanced Small Cell Lung Cancer Patients Previously Received Chemoradiotherapy: A Subgroup Analysis in ALTER 1202 Trial (Now Available) (ID 1698)

      13:30 - 15:00  |  Presenting Author(s): Qiming Wang

      • Abstract
      • Presentation
      • Slides

      Background

      The ALTER 1202 trial showed significant improvement in progress-free survival and well tolerant with anlotinib in advanced small cell lung cancer (SCLC) patients received at least two lines chemotherapy. Here, we reported the effect of anlotinib in patients previously received chemoradiotherapy.

      Method

      The ALTER 1202 was a randomized, double-blind phase 2 trial conducted at 11 centers in China. Patients with advanced SCLC that received at least two previous lines of chemotherapy were enrolled and randomized in a 2:1 ratio to receive either anlotinib or placebo until tumor progression or unacceptable toxicity. The subgroup analysis assessed the effect of anlotinib in patients with previous concurrent, sequential and alternate chemoradiotherapy. The primary outcome was progressive-free survival (PFS). The secondary outcomes were overall survival (OS), objective response rate, disease control rate and safety. Data are reported as per the 30 June 2018, data cutoff date. This trial is registered with ClinicalTrials.gov, number NCT03059797.

      Result

      Between March 30, 2017 and June 8, 2018, a total of 120 patients who met all eligibility criteria were randomly assigned to the anlotinib group (82 patients) or placebo group (38 patients). And 46 patients in anlotinib group and 22 patients in placebo group previously received chemoradiotherapy. Among them, the median PFS was 5.49 months (95% confidence interval [CI], 2.83 to 6.47) with anlotinib versus 0.69 months (95% CI, 0.66 to 0.76) with placebo (hazard ratio [HR], 0.14; 95% CI, 0.07 to 0.28; P<0.0001). Meanwhile, anlotinib significantly prolonged OS compared with placebo (9.49 months [95% CI, 7.29 to 12.68] versus 2.56 months [95% CI, 0.49 to 5.22]; HR, 0.46 [95% CI, 0.22 to 0.98]; P=0.0388) in patients previously received chemoradiotherapy. The most common adverse events were hypertension (39.13%), weight loss (39.13%), hypertriglyceridemia (36.96%) and leukopenia (30.43%). While, the most common grade 3 or worse adverse events were hypertension (15.22%), hypertriglyceridemia (10.87%), γ-glutamyl-transferase increased (8.70%).

      Conclusion

      Anlotinib improved PFS and OS in advanced SCLC patients previously received chemoradiotherapy and was well tolerated.

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    OA04 - Immuno Combinations and the Role of TMB (ID 126)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Immuno-oncology
    • Presentations: 1
    • Now Available
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      OA04.03 - A Randomized Phase 3 Study of Camrelizumab plus Chemotherapy as 1<sup>st</sup> Line Therapy for Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (Now Available) (ID 1682)

      15:15 - 16:45  |  Author(s): Qiming Wang

      • Abstract
      • Presentation
      • Slides

      Background

      Platinum-based chemotherapy remains 1st line therapy for advanced non-small cell lung cancer (NSCLC) without oncogenic drivers in China. Camrelizumab (SHR-1210, a potent anti‒PD-1 monoclonal antibody) has shown promising activity in multiple malignancies. Here, we report interim analysis results on efficacy and safety of camrelizumab plus carboplatin/pemetrexed as 1st line treatment in Chinese advanced/metastatic non-squamous NSCLC patients with negative oncogenic drivers.

      Method

      In this open-label, randomized, multicenter phase 3 study (SHR-1210-303), patients with advanced/metastatic, non-squamous NSCLC with negative EGFR or ALK were stratified by sex and smoking history (≥ 400/year versus ˂ 400/year) and were randomly assigned (1:1) to receive 4 to 6 cycles of carboplatin (AUC=5) plus pemetrexed (500 mg/m2) with or without camrelizumab (200 mg), followed by pemetrexed with or without camrelizumab as maintenance therapy up to disease progression or intolerable toxicity. Treatment was given every 3 weeks. Crossover to camrelizumab monotherapy was permitted for patients in the chemotherapy arm who had confirmed disease progression. The primary endpoint was PFS per blinded independent central review according to RECIST v1.1. Secondary endpoints included ORR, DCR, DoR and OS. Data of subgroup analysis will be reported. Clinical Trials.gov number: NCT03134872.

      Result

      Between May 12, 2017 and Jun 6, 2018, 419 patients were randomized, among whom 205 received camrelizumab plus chemotherapy and 207 received chemotherapy treatment. After a median follow-up of 11.9 months, median PFS was 11.3 months (95% CI 9.5‒not reached) in camrelizumab plus chemotherapy arm and 8.3 months (95% CI 6.0‒9.7) in chemotherapy arm (HR 0.61 [95% CI 0.46‒0.80], p=0.0002). ORR, DCR, DoR and OS with camrelizumab plus chemotherapy were superior to chemotherapy (Table 1). Grade 3/4 adverse events occurred in 66.8% of patients in camrelizumab plus chemotherapy arm and 51.2% of patients in chemotherapy arm. There were 5 treatment-related deaths in camrelizumab plus chemotherapy arm and 4 in chemotherapy arm.

      Table 1. Responses per blinded independent central review and overall survival in the total study population

      Camrelizumab plus chemotherapy

      (n=205)

      Chemotherapy alone

      (n=207)
      p-value
      Objective response rate 60.0% (53.0‒66.8) 39.1% (32.4‒46.1) p<0.0001
      Disease control rate 87.3% (82.0‒91.6) 74.4% (67.9‒80.2) p=0.0009
      Duration of response (months) 17.6 (11.6‒NR) 9.9 (8.5‒13.8) p=0.0356
      Overall survival (months) NR (17.1‒NR) 20.9 (14.2‒NR) p=0.0272
      Data are shown in % (95% CI) or median (95% CI). NR: not reached.

      Conclusion

      First-line camrelizumab plus chemotherapy shows substantial clinical benefit in patients with advanced/metastatic non-squamous NSCLC with negative EGFR or ALK in terms of PFS, ORR, and OS and acceptable safety profiles. The combination should become novel standard 1st line therapy for this population.

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-33 - Genetic Variants in FIG4 and IGF1R in the Endosome-Related Genes Are Associated with Non-Small Cell Lung Cancer Survival (ID 1483)

      09:45 - 18:00  |  Presenting Author(s): Qiming Wang

      • Abstract

      Background

      The endosome is a membrane-bound organ inside most eukaryotic cells and is known to play an important role in the adaptive immunity of mammals. The endocytosed antigens in the antigen presenting cells are delivered to both MHC class I and MHC class II pathways via the endosome.

      Method

      In the present study, we performed a two-phase analysis of two independently published genome-wide association studies (GWASs) to evaluate associations between genetic variants in the endosome-related gene-set and overall survival (OS) of patients with non-small cell lung cancer (NSCLC). In the discovery GWAS dataset, we performed multivariate Cox proportional hazards regression with Bayesian false-discovery probability ( 0.80) for multiple testing corrections and evaluated associations between 49,179 (3,735 genotyped and 45,444 imputed) single-nucleotide polymorphisms (SNPs) in 256 genes and survival of 1,185 NSCLC patients. After further validation in the Harvard Lung Cancer Susceptibility study, we performed linkage disequilibrium, functional prediction and a multivariate stepwise Cox model.

      Result

      We found that two independent, potentially functional SNPs in two genes (FIG4 rs6899506 C>A and IGF1R rs3743254 C>T) were significantly associated with NSCLC survival, and their meta‐analysis showed an adjusted hazards ratio (HR) of 1.16 [95% confidence interval (CI) =1.06–1.26, Pm = 0.001] and 0.78 (0.67-0.91, Pm = 0.002); respectively. A genetic score of unfavorable genotypes of these two SNPs revealed a decreased OS in a dose–response manner (P trend = 0.007). Further expression quantitative trait loci (eQTL) analysis showed significant associations between the genotypes and mRNA expression levels. It was found that the survival-associated FIG4 rs6899506C allele, but not the IGF1R rs3743254T allele, was significantlpdf转图片- 老版.jpgy associated with decreased mRNA expression levels of FIG4 in 373 lymphoblastoid cell lines.

      Conclusion

      Taken together, the genetic variant of the FIG4 rs6899506A allele and IGF1R rs3743254T allele from the endosome pathway genes may be a promising predictor of survival in NSCLC patients via FIG4 and IGF1R expression alteration.

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    P1.14 - Targeted Therapy (ID 182)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.14-54 - Previous Therapy Strategy Impact on Efficiency of Anlotinib Hydrochloride as 3rd Line Treatment: A Subgroup Analysis of ALTER0303 Trial (Now Available) (ID 1078)

      09:45 - 18:00  |  Author(s): Qiming Wang

      • Abstract
      • Slides

      Background

      Lung cancer remained one of the deadest cancers throughout worldwide. ALTER0303 trial revealed anlotinib might be used as a third-line or further treatment in non-small-cell lung cancer patients. While previous therapy strategy would have impact on efficiency of anlotinib still remained unknown.

      Method

      The subgroup of patients in ALTER0303 were analyzed by using Kaplan-meier estimates, Pearson X2 or Fisher exact test.

      Result

      There is no statistical significance on progression-free survival (PFS) and overall survival (OS) among patients in different previous antiangiogenic treatments groups. Patients in the chest radiotherapy (CRT) group had longer median PFS than non-CRT group (5.93m vs. 4.63m, P=0.027). No matter what kind of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKI) and chemotherapy regimens used previously, all patients gained longer PFS from anlotinib. While only patients treated with vinorelbine/platinum in EGFR wild type group, pemetrexed/platinum, vinorelbine/platinum and gefitinibin in EGFR mutation group, EGFR TKI used as the first line group could benefit from anlotinib on OS. When the OS was calculated from the time of diagnosis to death, anlotinib may improve about 6 months median OS (33.8m vs.27.8m, P<0.001) compared to placebo with HR (95%CI): 0.77 (0.60, 1.00).figure 1.jpgfigure 2.jpg

      Conclusion

      This study indicated previous bevacizumab or endostatin treatments had no impact on the efficiency of anlotinib. Patients with CRT history benefited more from anlotinib on PFS. EGFR TKI and chemotherapy treatments history had more impact on OS than PFS in patients treated with anlotinib compare to placebo.

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    P2.01 - Advanced NSCLC (ID 159)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.01-42 - ALK-Rearrangement May Promote VTE by Increasing the Expression of TF in Advanced Lung Adenocarcinoma (Now Available) (ID 1075)

      10:15 - 18:15  |  Author(s): Qiming Wang

      • Abstract
      • Slides

      Background

      Patients with lung cancer are at an increased risk for venous thromboembolism (VTE). About 8% to 15% of patients with advanced none small-cell lung cancer (NSCLC) experience a VTE throughout the course of the disease. However, the incidences of VTE in different molecular subtypes of NSCLC are rarely reported though they have big differentiation in clinical feature and prognosis. Tissue Factor (TF) expressed in many solid tumors could trigger the downstream coagulation cascade and lead to thrombin generation and clot formation.

      Method

      Here we extracted retrospective data from electronic medical records at Henan Cancer Hospital in China between January 2015 and January 2017. Advanced lung adenocarcinoma patients with ALK-rearranged, EGFR mutation and both negative were classified. The incidence of VTE of these patients were calculated. Then we randomly selected ALK-rearranged positive and negative lung adenocarcinoma tissues (N = 29, N = 26, respectively) and detected TF protein expression of the tissues with immunohistochemistry.

      Result

      The present study work flow in shown in Figure 1. At a median follow-up of 2.5 years, 5.85% (30 in 513) patients with advanced lung adenocarcinoma experienced VTE. ALK-rearranged patients (Figure 2A) were more likely to occur VTE than EGFR mutation and both negative patients (Figure 2C) (6 in 29, 20.69%; 11 in 218, 5.05%; 13 in 266, 4.89%, respectively P=0.018). In ALK-rearranged positive tissues, 41.67% (10 in 24) of them had a high expression of TF protein (Figure 2B) – the incidence was significantly higher than that of ALK-negative tissues’ TF protein expression (11.54%, 3 in 26, P=0.015) (Figure 2D). figure 1.jpgfigure 2.jpg

      Conclusion

      ALK positive NSCLC patients are more likely to occur VTE and this might be due to higher expression of TF in tumor tissues.

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    P2.12 - Small Cell Lung Cancer/NET (ID 180)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.12-11 - Quality of Life in ALTER1202 Trial of Anlotinib as Third-or Further Line Therapy for Advanced Small Cell Lung Cancer (SCLC): A Post-Hoc Analysis (ID 1300)

      10:15 - 18:15  |  Author(s): Qiming Wang

      • Abstract
      • Slides

      Background

      Anlotinib significantly improved progress-free survival of advanced small cell lung cancer (SCLC) patients in ALTER1202 trial. In this post-hoc analysis, we assessed the effect of anlotinib on health-related quality of life in ALTER1202 trial.

      Method

      In the randomised, phase 2, multicentre ALTER1202 trial, patients with advanced SCLC that received at least two previous lines of chemotherapy were enrolled from 11 centers in China. Eligible patients were randomly assign (2:1) to receive anlotinib or placebo. Health-related quality of life was assessed by EQ-5D scores. Patients filled out questionnaires at screening period and the end of each treatment cycle.

      Result

      Between March 30, 2017 and June 8, 2018, a total of 120 patients were enrolled. There were 119 patients with completed questionnaires at screening period, and 106 patients completed questionnaires at the end of the first treatment cycle (76 in anlotinib group, 30 in placebo group). EQ-5D scores had no significant difference between baseline and the end of the first treatment cycle in patients with anlotinib (0.85 versus 0.85, P=0.706). The median EQ-5D VASscores were 80.0 versus 85.0 in anlotinib and placebo group respectively (P=0.323) at screening period, and 90.0 versus 82.5 at the end of the first treatment cycle (P=0.273). The change of EQ-5D VAS scores from baseline to the end of the first treatment cycle was statistically significant (P=0.001) in patients with anlotinib compared to patients with placebo.

      Conclusion

      This post-hoc analysis showed that anlotinib maintained health-related quality of life in advanced SCLC patients.

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      P2.12-26 - The Impact of Anlotinib for Relapsed SCLC Patients with Brain Metastases: A Subgroup Analysis of ALTER 1202 (ID 489)

      10:15 - 18:15  |  Author(s): Qiming Wang

      • Abstract
      • Slides

      Background

      ALTER1202 trial (NCT03059797), a multicentre, randomized, double-blind phase II study has demonstrated that anlotinib significantly prolonged progress-free survival (PFS) in relapsed SCLC patients as 3rdor further line treatment. Here, we performed a comparative analysis for patients with brain metastases in the placebo and anlotinib arms.

      Method

      Eligible either limited- or extensive-stage SCLC pts who failed ≥2 lines of chemotherapy (n=120) were randomized 2:1 to receive anlotinib or placebo (12 mg QD from day 1 to 14 of a 21-day cycle) till progression or intolerable toxicity. The primary endpoint was PFS. This subgroup analysis was based on patients with brain metastases at baseline.

      Result

      There are 30 pts with brain metastases in anlotinib and placebo groups (n=21 vs 9). Anlotinib significantly improved PFS (3.84 vs 0.76 months; HR = 0.15; 95% CI, 0.04–0.51; P = 0.0005) and OS (6.08 vs 2.56 months; HR = 0.26; 95% CI, 0.09–0.73; P = 0.0061) comparing to placebo in patients with brain metastases at baseline. In anlotinib group, loss of appetite (47.62%), loss of weight (42.86 %), leukopenia (38.10%) and hypertriglyceridemia (38.10%) were the most common adverse events (AEs); then, in placebo group were emesis (44.44%) and loss of appetite (33.33 %).

      Conclusion

      For patients with brain metastases in ALTER1202 trial, significant improvement in OS and PFS were found in anlotinib treated group with a manageable safety profile.

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